System and devices for the repair of a vertebral disc defect

ABSTRACT

A system for repairing a vertebral disc defect, such as hernia or bulge, a full or partial tear in the annulus, or a weakened annulus wall as a result of an excision procedure. The system introduces a treatment device arranged to repair the defect, and may prevent the leakage of fluid from the nucleus. The components of the device may be resorbable materials, and may induce the ingrowth of cellular material into the components. The system may feature a locating device to ensure proper placement of the treatment device.

RELATED APPLICATION

This application is a Continuation of U.S. application Ser. No.11/187,064, filed on Jul. 22, 2005, now U.S. Pat. No. 7,824,414, whichis assigned to the same assignee as this invention, and whose disclosureis incorporated by reference herein.

FIELD OF THE INVENTION

The invention relates generally to methods and devices for humansurgery, and in particular these methods and devices may be useful forspinal surgery. More particularly, certain embodiments of the inventionrelate to devices and methods for treating injuries, defects or surgicalprocedures associated with the intervertebral disc.

BACKGROUND OF THE INVENTION

Injuries to the human spine and subsequent pain are one of the mostprevalent debilitating conditions affecting the human population. Formany of those affected, no position can ease the pain or discomfortassociated with spinal injuries or deformities. Such spine related paincan lead to decreased productivity due to loss of work hours, addictionto pain-killing drugs, emotional distress, and prolonged hospital stays.The economic impact of such problems is significant. One common causefor many instances of chronic pain is the bulging, or herniation of theintervertebral disc.

The intervertebral disc is made of two parts, a tough collagen outerlayer, known as the annulus fibrosus (hereinafter also referred to as“AF” or “annulus”), and a soft central core known as the nucleuspulposus (hereinafter also referred to as “NP” or “nucleus”). Theannulus is composed of numerous concentric rings or layers offibrocartilaginous tissue. Fibers in each ring cross diagonally, and therings attach to each other with additional radial fibers. The rings arethicker anteriorly (ventrally) than posteriorly (dorsally). The nucleusis a gelatinous material, which forms the center of the disc. The discstend to vary in size and shape with their position in the spine. Thenucleus is composed of a loose, nonoriented, collagen fibril frameworksupporting a network of cells resembling fibrocytes and chondrocytes.This entire structure is embedded in a gelatinous matrix of variousglucosaminoglycans, water, and salts. This material is usually underconsiderable pressure and is restrained by the annulus.

A tear or weakening in the layers of the annulus fibrosus portion of thedisc can allow the soft center portion of the disc (the nucleus) to leakout of the annulus, alternatively, the weakened annulus may simplybulge. A ruptured disc may allow the leaking nucleus pulposus materialto press up against a spinal nerve root or spinal cord, causing pain,numbness, tingling and/or weakness in a person's extremities. Herniateddiscs may occur at any level of the spine, but are more common in thelumbar area, followed in frequency of occurrence by the thoracic regionand cervical region. Weakening or tearing of the annulus fibrosus mayalso result in bulging of the annulus fibrosus due to pressure of thenucleus pulposus against the annulus. The bulging tissue may alsoimpinge upon the nerve root or spinal column, causing pain.

The traditional surgical method for treating a damaged, bulging, orherniated disc involves tissue removing procedures to relieve theimpingement of the annulus fibrosus or the nucleus pulposus from thesurrounding nerves. The procedure is commonly known as a discectomy, andconsists of the removal of at least a portion of the disc; it may beperformed in an open procedure, a minimally invasive procedure, or anendoscopically assisted procedure. These procedures generally result ina large defect of the annulus fibrosus and in a certain percentage ofcases, may lead to progressive degradation of the disc, both nucleuspulposus and annulus fibrosus, listhesis of adjacent vertebral bodies,stenosis of the nerve canals and increases in related pain symptoms. Ameans of mechanically and/or biologically repairing the annulus fibrosusmay delay or prevent this degeneration cascade of the disc.

Newer technologies and procedures, such as nucleus replacement withinjectable or solid prosthetic nucleus devices may also result in abreach in the otherwise coherent annulus fibrosis. In these cases, it isdesirable to mechanically close, or otherwise repair the defect in theannulus created to insert the prosthetic material and prevent suchmaterial from leakage and extravasation.

The annulus fibrosis (AF) of the intervertebral spinal disc is alamellar configuration of collagen layers intended to maintain the softviscous internal nucleus pulposus (NP), provide for motion and linkageof the adjacent vertebral bodies (VB). Certain degenerative orpathologic changes may occur either within the NP which can lead to overstress of the AF and subsequent damage to or tearing of the AF. If leftuntreated, herniation of the NP may occur, most importantly, theherniation may progress posteriorly toward the spinal cord and majornerve roots. The most common resulting symptoms are pain radiating alonga compressed nerve and low back pain, both of which can be crippling forthe patient. The AF may also be torn through traumatic injury, which canlead to progressive degenerative changes and herniation or ultimatelylisthesis of the adjacent VB, degenerative changes in the lumbar spinethat may result in a loss of spinal stability and subluxation of onevertebra relative to another.

Herniation may be caused by, or be the result of weakening in the AF.Secondary to physiologic changes of the AF or NP, the AF may weaken andprotrude from its normal anatomic space, similar to an air bubble bulgein a car tire, or in more severe cases, the AF may tear and allowextravasation of the NP contents to the surrounding anatomy. Symptomsmay arise when the herniation or leakage of the NP impinges on the nerveroot or spinal cord. There are therapies currently utilized fortreatment of the herniation of a vertebral disc, and the resultant pain,starting with conservative therapies such as bed rest and painmedicines, to more invasive therapies, such as epidural injections, openor minimally invasive discectomies or aggressive therapies, such ascomplete discectomy and fusion of the disc space and adjacent vertebrae.

The prior art describes various procedures and devices for repairingdamage to the vertebral disc. The prior art describes repairing aherniated disk by various means, including prosthetic implants, andstressed members. For example, in U.S. Pat. No. 6,805,695, Keith et al.disclose devices and methods of reinforcing an annulus of the disc byintroducing a circumferential reinforcement member around the annulus ofthe disc, or through the annulus and nucleus of the disc.

In U.S. Pat. No. 6,371,990, Ferree discloses an apparatus and method forrepairing annular tears and the prevention of further annular tears.Ferree seeks to control vertebral motion by augmenting the annulus withan implant, thereby minimizing the opportunity for annular tears. Theaugmenting implant is described as being a mesh that may be stapled intothe interior of the annulus.

Ferree also discloses in U.S. Patent Application 2004/0097980 anexpandable material to fill a defect in a disk, and that the materialmay be anchored to the annulus with respect to the void filled. In anembodiment, the anchors are described as penetrating through the outerwall of the disc and serve to hold the flexible implant material inplace.

Yeung discloses in U.S. Pat. No. 6,530,933 a method and apparatus forherniated disc repair using resilient fastener elements that areimplanted and spring back to an original shape to apply tension throughgripping elements to hold tightly to the annulus. In an alternativeembodiment, the annulus repair technique utilizes a suture affixed to adumbbell shaped rod to serve as an anchor. The anchor is placed againstthe outside surface of the annulus, and the suture extends across theinterior of the vertebral disc through the nucleus pulposus and out theother side of the disk, such that tension may placed against the disc torepair the hernia, and the tension may be maintained through the use ofa washer and suture locking element, such as a knot. With thisalternative embodiment, a sealing material may optionally be placedunderneath the washer.

In U.S. Pat. No. 6,592,625, Cauthen describes annular repair orreconstruction by insertion of a collapsible patch into the subannularspace, whereupon the patch expands to fill the gap and seal off theopening from the escape of nucleus material. Cauthen describes hisdevice as being useful to restore integrity after damage or discectomyto alleviate a herniated vertebral disc; Cauthen does not obviate theneed for the discectomy procedure to repair a herniated disc.

In U.S. Pat. No. 6,224,630, Bao describes the repair of anintervertebral disc using an expandable porous material that is insertedinto an aperture, and subsequently becomes more permanently secured asthe ingrowth of tissue into the pores is actively facilitated. Baocreates a device having a tamponade effect where the swelling of thematerial provides securement and does not describe a more securemechanical anchorage using a rigid component in combination with atissue regenerative material.

The prior art also describes various methods for sealing a percutaneousclosure, for example, Kensey et al. in U.S. Pat. No. 5,545,178 describea system for sealing a puncture made through skin and having a tractextending through to underlying tissue. The puncture closure systemconsists of an anchor introduced into the underlying tissue and having afilament attached thereto, the filament extends out from the puncture,and facilitates the introduction of a plug material into the tract,whereupon tension is maintained through the use of a holding member.Kensey et al. does not describe the sealing of multiple sites throughthe employment of a single device, nor is the employment of multipleanchors or plugs on a single filament described.

In U.S. Pat. No. 6,136,010, Modesitt et al. describe a system forsuturing vascular puncture sites located at the distal end of apercutaneous tissue tract. The system consists of a suture introducedinto the tissue surrounding the puncture. Said system is not suitablefor closing defects in the annulus as it relies on the ability tore-approximate tissues around a defect in order to close the opening andprevent tissue from exiting through the puncture.

In U.S. Pat. No. 5,728,114, Evans et al. describe an apparatus forreducing bleeding from a percutaneous arterial puncture. The apparatuscomprises a mass of material for inhibiting blood flow, a suture, andmeans for holding the material at the desired site. For reasons thatwill become apparent later, said system is not optimal for closingdefects in the annulus as it is better suited to deliver a material tothe outside of a tissue defect.

The prior art does not describe a device wherein the device may becapable of being implanted arthroscopically, among other methods knownin the art, and is arranged to prevent the escape of nucleus pulposusfrom a defect in the annulus, while providing support to the defect,securement, and effective sealing means in a single device.

Accordingly, there is a need for a system or device that is capable ofmeeting these and other objectives, wherein the system provides meansfor minimally invasive delivery of a device that provides tissuesupport, incorporates a barrier element to assist with defect closure, asecure sealing means for positioning at the defect, securement means forholding the device in place, as well as the ability to provide forcellular infiltration and subsequent repair occurring in or around theannulus fibrosis. Furthermore, there is a need for a device capable ofpreserving or restoring normal annulus geometry (e.g., repairing aherniated disc), wherein there is support and secured sealing providedat each point of penetration or defect in the annulus.

It is the intent of the present invention to overcome these and othershortcomings of the prior art.

SUMMARY OF THE INVENTION

Various embodiments of the current invention strive to overcome thesevarious shortcomings in the prior art. These embodiments allow forsingular devices, or combinations of barriers, anchors or fasteningdevices which prevent the escape of nucleus material or nucleusreplacement and/or other therapeutic materials while providing supportto the annulus, sealing elements, securement elements, as well ascomponents for restoring or maintaining satisfactory disc geometry andproviding the scaffold for regeneration of the damaged annulus and othertissues.

Certain of these embodiments have barriers and or anchors (e.g.membranes, plates, fabrics, meshes, anchors, etc.), which may bedeployed in a manner associated with one or both sides of the annuluswall. The barrier member, or barrier means, serves to bridge any gapbetween the opposing edges of the opening or defect. Once the barrier issecured adjacent to the defect, it serves to prevent tissues, such asnucleus material, from migrating through the defect. The barrier mayalso be suitable for helping to contain nucleus replacement materialswithin the nucleus portion of the annulus. In some instances, theopening in the annulus will be such that the edges of the defect can bedrawn together with the filament portion of this invention. In thisinstance, the barrier provides reinforcement or support to the tissue atthe defect site. In some embodiments, securement of the barrier to thedefect site will thereby create and exert pressure on the annulus wall.This pressure alone may serve to support and/or seal the annulus. Insome embodiments, combinations of barriers are used at multiplelocations with respect to the annulus. The barriers themselves mayfeature or further be utilized in combination with a sealing means(e.g., elastic biomaterials, patches, collagen, adhesive, thrombin,hydrogel, etc.) that may be beneficial or necessary to aid sealing. Thevarious embodiments of the invention contemplate the use of a variety ofdevices including, but not limited to patches, plugs, staples,expandable materials, meshes, anchors, sutures, flowable materials,sealants, glues, gels and other wound and tissue repair devices known inthe art. To that end, a barrier member may be rigid, compliant, orelastic; furthermore, the barrier member may be a composite of variousmaterials, which are, separately or together, best suited for supportand/or sealing functions. Such components may comprise materialsinherently radiopaque or they may be treated with substances which makethem radiopaque when viewed under any imaging techniques utilized by thesurgeon to visualize placement.

Several embodiments of the present disclosure utilize connecting means.The connecting means, connecting member, or connecting element, as theterms may be used interchangeably herein, may be comprised of a numberof elements known in, or common to, the art including but not limited tofilaments, suture, fabric, threads, ribbon, wire, etc. In a preferredembodiment, the system may be adapted for various types of deployment,such as, portion of the connecting means may be positioned through thetissue that is adjacent to the defect or opening in the annulus. A novelaspect of some embodiments of this invention is a delivery system thathas the ability to deliver connecting means through the tissue adjacentto the defect. In some embodiments, a portion of the filament orconnecting means may be positioned to extend through the defect oropening in the annulus. In some instances, a portion of the connectingmeans is intended for passage through the same puncture through whichthe delivery instruments access the annulus and nucleus tissues. Ingeneral, the connecting means can be used in conjunction with one ormore of the barrier, sealing, or securement means to aid in the closureand or repair of the defect.

Several embodiments of the present disclosure utilize at least onesealing means. The sealing means, or sealing member, as the terms areused interchangeably herein, may be most beneficial if placed at theoutside of the wall of the annulus, though it may also be placed withinthe wall of the annulus, depending on the geometry of the device, thetype of sealing means, and the geometry of the affected anatomy. Thatbeing said, the sealing means can be positioned in a number of locationsdepending on the defect being treated. For example, it may be desirableto have some portion of the sealing means extend into the wall of theannulus and potentially into the NP. Furthermore, the seal may be placedproximal or distal to the fastening device(s). It is recognized that theforce internal to the annulus (i.e., the force from the fluid nucleuspulposus) may assist sealing by pressing the sealing means against theannulus, where such sealing means may be preferably located internal tothe annulus. The sealing means may be used as a scaffold to help withthe repair of the defect. The sealing means may serve as a tissueregeneration guide and may also serve to deliver appropriate agents tothe tissue defect.

Several embodiments of the present disclosure utilize at least onesecurement means, or securement member, as the terms are usedinterchangeably herein. The securement means may be used in someembodiments to secure the filament and or barrier element at the defectsite. The securement means can be stored within the instrument of theinvention or added to the device externally and positioned at a locationsuitable to secure the device. For example, a surgeon can form a knot onthe filament portions of several embodiments of this invention and slidethe knot adjacent to the tissue defect to secure the device in position.The various embodiments of the invention contemplate the use of asecurement means including devices capable of maintaining tension placedon the connecting means or maintaining the desired positions of thedevice components, including, but not limited to, locking components,knots, plugs, staples, locking washers, slidable components, deformableelements, expandable materials, sealants, glues, gels and other devicesknown in or common to the art.

Overall disc or annulus geometry may be beneficially altered by placinga device at or through a distal wall of the annulus, while placing asecond device at or through the proximal wall, where the devices areconnected, e.g., by a tether, suture, flexible, or rigid member. Thistype of device would allow compression to be placed across each discwall, while simultaneously compressing or restraining the disc acrossits diameter. Again, sealing means may be employed, as previouslydiscussed.

These various embodiments may be particularly useful in the situationwhere the annulus is torn. Since the annulus is fibrous, tears generallyoccur in the circumferential direction (i.e., not purely radial) alongat least a portion of the fibers. Deploying a device across the tearcould cause compression to be placed across the torn annulus surfaces,thereby allowing the combination of securement and friction (therebyrestricting movement of the torn surfaces against each other) to holdand support the annulus.

Commonly, discectomies or laminectomies are performed to relieve pain.These embodiments may augment, if not replace these types of procedures.That is, multiple fasteners, or a single through-wall fastener, may beplaced proximal and distal to the annulus entry tract (in the case of adiscectomy), and a sealing patch may be placed adjacent either fastener,or the sealing patch may reside mid-wall to the annulus.

It is also recognized that a sealing member may function as a fasteneritself, thereby minimizing the number of device components, proceduralsteps, and/or procedural time. To that end, a sealing member may berigid, compliant, or elastic; furthermore, the sealing member may be acomposite of various materials, which are best suited for support andsealing functions. As a non-limiting example, such fasteners may becomprised of a rigid polymeric backing material (which may or may not beresorbable, e.g., PLA or polyurethane) which has a layer that contactsthe tissue which comprises a malleable material, which may or may not beresorbable (e.g. polymer, collagen, etc.) to seal the tear orprocedurally made opening. Such components may be comprised of materialsinherently radiopaque or treated with substances which make themradiopaque when viewed under standard imaging techniques to allow thesurgeon to visualize placement.

These various embodiments may be at least partially made from permanentor biodegradable materials such as those listed in Table 1, and thesedevices may have a secondary or tertiary effect by the delivery of drugsor biologics such as those listed in Table 2. In an embodiment of afastening or sealing device made from the materials described above,once implanted in a living being, the device may cause or induce the newgrowth or regrowth of cellular material. In this embodiment, thematerial encourages the ingrowth of cellular material that securelyintegrates the device into the surrounding tissues, thereby repairingthe weakened area in a more effective manner.

In the embodiment where the device is a resorbable material, theingrowth of cellular material into the device allows for a permanentrepair upon complete resorption of the resorbable device, as thematerial is replaced by the growth of cells to create a natural tissuematerial similar to and integrated with the surrounding structures.

In the embodiment where the device is a non-resorbable material, theingrowth of cellular material into the device allows the completeintegration of the device with the surrounding tissue, thereby creatinga suitable repair having nearly similar compliance and other physicalcharacteristics as the original tissue material.

Several embodiments of the present disclosure utilize at least oneelongated delivery means, instrument, or member, as the terms are usedinterchangeably herein. The elongated delivery means may be used in someembodiments to position or deposit the device components (e.g. barrier,filament, securement element, sealing means, etc.) at a desired locationwith respect to the defect site. The elongated instrument is suitablefor being arranged through the defect or an opening at a location torepair the defect or opening.

In yet another embodiment, the treatment device comprises an elongatedinstrument, at least one bridging member, and a plurality of connectormembers. The elongated instrument may be placed in or near the defect,where it is used to deliver the at least one bridging member inside ofthe intervertebral disc. The elongated instrument may then displace thebridging member from the deployed position, to a position against theinside wall of the disc. This placement should cover at least a portionof the defect. Additionally, the connector members may be deployed fromthe elongated instrument into tissue at or near the defect and therebyengage the at least one bridging member such that the bridging member issecured against the wall of the disc. This embodiment will affordsupport to the defect area of the disc.

This embodiment is envisioned to be operative with various otherembodiments in the present disclosure. For example, the device mayadditionally include a fastening element, wherein the fastening elementacts cooperatively with the connecting means to secure the bridgingelement against the disc. Various or all of the members and componentsof this embodiment may be resorbable, and located or positioned asdescribed elsewhere herein, or by methods known to those in the art.

In certain embodiments the delivery instrument may feature at least onepassage element, which may be capable of providing a means for directingor passing at least one connecting member through tissue adjacent to thedefect site. A portion of the passage element, passage member, orpassage means (e.g. needle), in some embodiments, can be made totemporarily extend from a portion of the elongated delivery instrumentinto the adjacent tissue for the purposes of passing a portion of theconnecting element into the tissue. Preferably, the passage element canthen retract into the elongated delivery instrument prior to deviceremoval.

In some embodiments the delivery instrument comprises means forpositioning the connecting element(s) into a position for optimalpassage through the tissue adjacent to the defect site. The positioningmeans, positioning member, or at least one positioning element, in someembodiments, can temporarily extend axially from a portion of theelongated instrument, (e.g., into the adjacent tissue) for the purposesof cooperating with the passage element in order to position a portionof a connecting element into and or through the tissue adjacent to thedefect. Preferably, the positioning means can be retracted into theelongated delivery instrument prior to device removal.

Procedurally, these various embodiments may be delivered from posterioror anterior directions, based on the anatomical constraints as well as,among other things, herniation, disease, or type and geometry of thedefect. While it is envisioned that similar, if not the same, deliverydevices and methods may work for posterior as well as anteriorprocedures and placements, certain types of procedures may benefitgreatly from devices or embodiments which sense their location or detectwhere they are located in the anatomy. For many annulus repair devicesit may be beneficial to utilize minimally invasive methodologies toposition the device. Minimally invasive procedures utilize laproscopicor endoscopic instruments to perform procedures through small openingsin a patient's skin and can result in less trauma and faster healingtimes for the patient. However, such approaches are challenging in thatthe physician may not be able to directly visualize many aspects of theprocedure. It has been discovered through experimentation in ex-vivomodels that several embodiments of the devices of this invention canbenefit by using delivery systems that can locate the transition betweenthe annulus and the adjacent tissues to ensure proper device placement.

Location detection devices are known in the art, for example U.S. Pat.No. 5,282,827, assigned to the assignee of the present disclosure, maybe used to accurately place a hemostasis device in an artery (deliveryof a hemostasis device using a location detector) also assigned to theassignee of the present disclosure. However, while these aforementioneddevices may perform suitably for the currently contemplated procedures,certain modifications could improve their performance. That is, theannulus pulposus, as well as certain of the surrounding fluid, isnormally more viscous and less able to flow to provide the “perceptiblesignal” of the aforementioned patents.

In order to improve upon these previous embodiments, the locationdetection means incorporated in the current embodiments may furthercomprise instrumentation or other features allowing for accurateplacement of the device percutaneously. Such instruments may becalibrated at some portion so as to allow the surgeon to determine theexact thickness or dimension of the spinal disc component to betraversed with the fixation device. These placement instruments can alsobe comprised of an actual depth measurement instrument whereby thesurgeon can engage the aspect of the disc to which the distal mostportion of the device should engage and then determine the traversingdistance. A location detection means may also beneficially stabilize thedelivery system for the placement of a repair device in anintervertebral disk.

DESCRIPTION OF THE DRAWINGS

FIGS. 1-3 depict overhead cross-sectional views of a vertebral dischaving a defect therein, in the form of an annulus wall having a reducedthickness, a partial tear, and a full tear, respectively.

FIGS. 4-8, and 11 provide a depiction of the placement of variousclosure or treatment devices of the present invention.

FIGS. 9 and 10 illustrate various barrier members for use with thepresent invention.

FIG. 12 is a cross sectional depiction of a cannula and obturator forthe implementation of the present invention.

FIG. 13 is a partial cross-section of embodiments of the delivery deviceand portions of the treatment device of the present invention.

FIG. 14 is another embodiment of a treatment device and the deliverydevice, housed within the access sheath.

FIG. 15 illustrates a cannula and access sheath of the present inventionincorporating a location detector means.

FIG. 16 An access cannula (e.g. needle) positioned into the defect ofFIG. 30.

FIG. 17 depicts an exploded profile view of a cannula and obturator.

FIG. 18 shows an exploded profile view of a guidewire and cannula.

FIG. 19 shows an elevated view of the Guidewire positioned into theaccess cannula and directed into the disc of FIG. 16.

FIG. 20 shows an elevated view of the Guidewire of FIG. 19 remaining inplace as the access cannula is removed from the patient.

FIG. 21 shows an elevated view of the positioning of an Access sheathover the Guidewire of FIG. 20.

FIG. 22 shows an elevated view of the Access sheath of FIG. 21 as theobturator (e.g. dilator) and guidewire of FIG. 21 are removed.

FIG. 23 shows an elevated view of the activation or deployment of alocation detector on the access cannula of FIG. 22.

FIG. 24 shows an elevated view of the retraction of the access sheathand deployed location detector of FIG. 23.

FIG. 25 shows an elevated view of a deployment of a locking ring on theaccess sheath of FIG. 24.

FIG. 26 provides an elevated view of the access sheath of FIG. 25 anddepicting the introduction of the delivery system into the accesssheath.

FIG. 27-32 depict elevated profile views and illustrations of thedeployment and securement of the closure device of the delivery systemof FIG. 26.

FIGS. 33 and 34 show overhead cross-sectional views of a vertebral dischaving a defect therein, in the form of a hernia or bulge in theannulus, having an intact annulus or extravasation of the nucleus.

FIGS. 35-38 depicts the placement of various closure or treatmentdevices of the present invention.

FIG. 39 illustrates overhead cross-sectional views of a vertebral dischaving a nucleus implant material placed into the nucleus.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Repair of Tears of theAnnulus Fibrosis

The annulus fibrosis (AF) of the intervertebral spinal disc is alamellar configuration of collagen layers intended to maintain the softviscous internal nucleus pulposus (NP), provide for motion and linkageof the adjacent vertebral bodies (VB). Certain degenerative orpathologic changes may occur either within the NP or the AF which canlead to over stress of the AF and subsequent damage to or tearing of theAF. If left untreated, herniation of the NP may occur through the tear,and most importantly, the herniation may progress posteriorly toward thespinal cord and major nerve roots. The most commonly resulting symptomsare pain radiating along a compressed nerve and low back pain, both ofwhich can be crippling for the patient. The AF may also be torn throughtraumatic injury, which can lead to progressive degenerative changes andherniation or ultimately listhesis of the adjacent VB.

An embodiment of the present invention is intended to provide means bywhich the AF can be compressed, e.g., along, or across, as appropriate,the axis of tear, thereby preventing the potential herniation of the NPthrough the tear and resultant pain.

FIG. 1 shows a transverse section of the intervertebral disc spacebetween two adjacent vertebral bodies. The intervertebral disc 16contains the annulus fibrosis (AF) 3, which surrounds a central nucleuspulposus (NP) 4. Also shown in this figure are the spinal cord 1 and thenerve roots 2. In FIG. 1, the annulus is depicted having a defect 9therein, wherein the thickness of the annular wall is reduced, as mayoccur through, for example, a full or partial discectomy procedure,where the removal of at least a portion of the annular wall may benecessary, commonly to minimize the effects of herniated discs. Withreference to FIGS. 2 and 3, the defect 9 may be in the form of anannular tear, as depicted by the solid black line through the AF, as mayoccur in the course of surgical procedures, injury, or naturaldegradation of the annulus fibrosus. A defect, as used herein, refers toany variation or anomaly from the normal presentation of the annulus,and the term is deemed to include, for example, full or partial tears,full or partial excisions, holes, bulges, degradation, thinning,hyperplasia, or thickening of or in the annulus material. As will bedescribed more fully below, the damage or defect 9 depicted in FIGS. 1,2 and 3 may be repaired in various manners through the practice of thepresent invention, for example as can be seen respectively in FIGS. 4-8.

In order to repair these defects, whether full or partial, the device ofthe present invention may serve to fill the defect and/or applycompression to the annular wall. Furthermore, the present invention mayserve to reinforce the defect area, thereby preventing furtherherniation of tissue (e.g., NP) or the expulsion of nucleus replacementdevices or other materials. The defect 9 created by a discectomyprocedure may fully penetrate the annulus, extending through to thenucleus pulposus, and forms an opening in the annulus, requiring repairin order to prevent the extraversion of the nucleus.

As can be seen by example in FIG. 4, one embodiment of the implanteddevice consists of a barrier element or anchoring member 5 placed withinor near the defect 9 in the annulus, preferably placed against aninterior aspect of the annulus such that the barrier overlaps the defectarea, thereby covering the defect and extending beyond the defect area.The barrier element is connected to at least one securement element 17by way of at least one connecting member 6, here depicted as a pair ofconnecting members 6, thought it is also recognized that additionalconnecting members and arrangements of the connecting members may bebeneficial. The connecting members 6 extend through tissue adjacent thedefect 9, or directly through the defect 9 and are affixed to at leastone securement element 17. In this manner, the barrier 5 is securelyfixed in place against the annulus tissue 3, and is able to effectivelyseal the opening or defect, thereby preventing the escape of nucleus orimplanted material within the nucleus, through the defect 9. The closureof the defect or opening is thereby achieved without requiring thestretching tissue adjacent the defect, where tension applied to thesutures directed through the tissues pulls the tissue faces together toseal the defect. The type of closure, relying on a barrier to cover thedefect is better suited for use with the tough tissue characteristics ofthe annulus.

In some embodiments, at least one sealing member 8 may be depositedwithin or against the tissue of the annulus, either directly in thedefect or near the defect 9, and may serve to ensure an adequate closureof the defect. The sealing member may also be secured with a filament orconnecting member 6. The connecting member 6 may preferably be a suture,filament, thread, fabric, or other flexible member. The connectingmember may be manufactured from materials known in the art, e.g.,synthetic polymers, natural polymers, metal, etc., and may be resorbableor non-resorbable. The barrier 5 may be constructed of a biocompatiblematerial (e.g., polyurethane, resorbable polymer, resorbable collagen orother resorbable or non-resorbable material). The barrier may be rigidas is the case with a polymer or metal anchor, or the barrier may beflexible such as a fabric or other textile such that it may conform tothe tissue. The barrier as used in the practice of the present inventionmay be arranged to serve as an anchoring means for the device, andoptionally may serve as a sealing means. The implantable components(e.g., the barriers, sealing members, connecting elements, intermediarycomponents, fastening elements, etc.) of the present invention may bemanufactured from a variety of biocompatible, resorbable ornon-resorbable, materials, examples of which can be found in anon-exhaustive list supplied as Table 1 below.

In some embodiments of the present invention, as shown in FIGS. 5, 6, 7,and 8, the device is capable of applying and maintaining a compressiveforce between the outer and inner aspects of the AF 3 at the point wherethe defect or tear 9 exists, thereby serving as a treatment device tofacilitate healing. With reference to FIG. 7 as an example, oneembodiment of the implanted device consists of a barrier element 5placed internally of the annulus, which is connected by way of aconnecting member 6 to a sealing element 8, placed externally to theannulus. The connecting member passes through the annulus tissue 3adjacent to the defect 9 and may preferably be a suture, filament,thread, fabric, or other flexible member. Alternatively, the connectingmember may be a rigid member capable of resisting the free movement ofassociated barrier element or sealing members, and intermediarymaterials. The rigid connector element may be capable of resisting anencountered force, and also serve to maintain tension upon the tissuerestrained by the treatment device. The connecting member may bemanufactured from materials known in the art, e.g., synthetic polymers,natural polymers, metal, etc., and may be resorbable or non-resorbable.The barrier 5 may be constructed of a biocompatible material (e.g.,polyurethane, resorbable polymer, resorbable collagen or otherresorbable or non-resorbable material). The barrier may be rigid as isthe case with a polymer or metal anchor, or the barrier may be flexiblesuch as a fabric or other textile to conform to the tissue, in anyevent, where tension is maintained upon the connecting member 6 againstthe barrier, the barrier must be able to resist being pulled through thedefect or opening in the annulus, and prevent the escape of materialswithin the annulus through the defect 9.

FIG. 6 illustrates one embodiment of the present invention for treatinga tear in the annular wall. In a similar fashion to examples alreadydescribed, a barrier element 5 is placed internally of the annulus,which is connected by way of connecting members 6 to a securementelement 17, placed externally to the annulus. In the embodiment shown inFIG. 6, the tension maintained by the placement of the closure deviceserves to assist with repairing the defect, and or allow for healing tooccur, as the compression applied by the device is able to maintain therelative positions of the tissues adjacent the defect.

In another embodiment, as depicted in FIG. 7, a barrier 5 may be placedinternally to the annular wall 3, connected to connecting members 6,extending through the tissue adjacent the defect and associated with asealing member 8. This sealing member 8 may beneficially be a non-rigidmaterial, however, the physical characteristics of the sealing plug aresuch that it will deform to fill and or conform to the defect 9. Asecurement element, would preferably be utilized, though the sealingmember 8 may also serve as a securement element. For example, thesecurement element may be in the form of a sealing material that swellsor changes conformation upon implantation, such that the connectorelement may be secured, thereby maintaining the tension or applicationof compressive force upon the defect.

FIG. 8 represents another embodiment of the present invention fortreating a tear in the annular wall, although it is recognized that afull tear, partial tear or other defects could be treated in similarfashion. With reference to FIG. 8, this embodiment of the implanteddevice consists of a barrier element 5 placed internally of the annulus,which is connected by way of a connecting member 6 to a securementelement 17, placed externally to the annulus, and includes sealingmember 8 placed within the wall of the annulus 3 and/or within thedefect 9. In some embodiments of the present invention, the sealingmember 8 may serve to deliver a therapy (e.g. for the purpose ofmoderating inflammatory response, aiding healing, etc.), such as abiologically active agent, examples of which are listed in Table 2. Thesealing member 8 may consist of a flowable or expandable material (e.g.hydrogel, adhesive, packing material, etc.) that serves to aid insealing or adhering the tissue, so as to prevent the flow of materialinto or out of the NP (e.g., loss of NP, or inflow of blood, etc.)through the defect 9 in the AF 3 (e.g. a plug). This may be accomplishedby providing a sealing member 8 that is able to conform to the shapesand surfaces of the defect 9. It is recognized that the sealing membermay be delivered as a rigid material that is able to swell upon beingimplanted in the body, effectively sealing the defect from theextravasation of nucleus material. The sealing member may additionallyfeature a natural material that can act as a matrix for cellularinfiltration and regeneration of the annulus. The sealing member 8 mayalso be secured with a connecting member 6′ which, in this depictedembodiment, intersects at least a portion of the defect 9. As shown,connecting members 6 extend through the tissue at locations adjacent todefect 9. The connecting members may preferably be a suture, filament,thread, fabric, or other flexible member but may also be a rigid memberas described previously. The connecting members 6 and 6′ may bemanufactured from materials known in the art, e.g., synthetic polymers,natural polymers, metal, etc., and may be resorbable or non-resorbable.The implantable components (e.g., the barriers, sealing members,connecting elements, intermediary components, fastening elements, etc.)of the present invention may be manufactured from a variety ofbiocompatible, resorbable or non-resorbable, materials, examples ofwhich can be found in a non-exhaustive list supplied as Table 1 below.

As can be seen in FIGS. 9 A, B, C and 10 A and B, the barriers may be ofany shape or configuration that is suitable for delivery to the defectsite and capable of resisting being pulled back through a defect afterdeployment. The barriers may preferably have several connecting elementsattached at various locations of the device. In some instances, as isshown in 9 a, 9 b, and 9 c, several of the connecting elements 6 arelocated at the periphery of the barrier and these connecting elements 6are intended for passage through tissue adjacent an annular defect. Inthese instances, four connecting elements 6 are located at the peripheryof the barrier element 5 and serve to anchor the barrier 5 to the tissueadjacent to the defect. It is recognized that any number of connectingelements can be used depending upon the geometry and size of the barrierand defect to be treated. In some instances, for example as shown in 9b, at least one connecting member 6′ can be located near the center ofthe barrier. Portions of these non-peripheral connecting elements 6′ areintended for passage either through the defect itself or through thepuncture through which the delivery instrument has passed. The barriers5 may be constructed of a biocompatible material (e.g., polyurethane,resorbable polymer, resorbable collagen or other resorbable ornon-resorbable material). The barrier may be rigid as is the case with apolymer or metal anchor, or the barrier may be flexible such as a fabricor other textile as described previously. The barriers may berectangular in shape as shown in FIGS. 9A and 9B, circular/oval as shownin 9C, or any desirable shape. The barriers may also be formed into3-dimensional structures to help them best seal and repair the defect.As shown in FIG. 9C, the barrier may be comprised of a flexible membrane50 (e.g. polyurethane mesh, collagen sheet, etc.) and a reinforcingexpandable membrane 52 (e.g. nitinol wire, polymer ring, etc.). Thebarrier of FIG. 9C is suitable for being collapsed and stored within theelongate delivery instrument and, upon delivery into the area adjacentto the defect, the reinforcing membrane 52 causes the barrier 5 toresume its original oval shape so that is may conform to the defectsite. As shown in FIG. 9C the barrier may be attached to severalconnecting elements 6, in this case 4.

As illustrated in FIG. 10A, the barrier 5 may also contain small barbsor points 7 to interface with the internal or external surface of the AFor surrounding tissue to aid in securing the device and prevent it frombeing dislodged.

As illustrated in FIG. 10B, the barrier may consist of multiple barrierelements that once deployed are able to seal the defect and/or resistbeing pulled through the defect. The device of FIG. 10B is suitable forbeing collapsed and stored within the delivery instrument in a firstconformation, and upon delivery into the area adjacent to the defect,barrier may arrive at a second conformation, for example, the elements54 of FIG. 10A can pivot at location 55 and expand into the barrier 5 ofcruciform shape shown. It is recognized that barriers 5 may bespecifically shaped for a particular purpose, that is, barriers intendedto be inserted into the interior of the annular wall may have a firstorientation, shape, or curvature, while another barrier intended for useoutside of the annular may feature a second orientation, shape orcurvature.

It is also recognized that various arrangements of barriers andconnecting members may be necessary. For example, it might be beneficialto utilize a single barrier on the exterior of the annulus, and place aplurality of barriers in the interior of the annulus, all connected byat least one connecting member, or alternatively, the arrangement may bereversed, with a single interior barrier and a plurality of exteriorbarriers. It is recognized that the barriers described above mayadditionally feature some application (e.g. coating) of a sealingmaterial (to be discussed below) to aid in maintaining annulus integrityagainst leakage. The barriers, or other members, may also contain amarker, additive, or other material that can be visualized with x-ray orother imaging technologies to assist with the placement of the deviceand potentially allow for longer term follow-up of the device location.

The materials of the present invention that are resorbable may comprisea porous tissue matrix material (PTM). This PTM material will preferablyhave an interconnected porosity, and sized to encourage the invasivegrowth of new cellular material. The interconnected porosity also servesto ensure adequate fluid flow to provide an optimal growth environmentfor the invasive cells. The ingrowth of new cellular material willbeneficially encourage the incorporation of the device material into thenearby tissues, and provide for biomatching or compliance matching,where the device material and components present similar physicalcharacteristics as the original tissue.

Referring to FIG. 11, where the defect 9 extends fully through theannular wall, and may be created, for example, as a consequence of afull discectomy, the intermediate or sealing component 8 is preferablycapable of filling the entire defect void created by the removal of aportion of the annulus. The sealing member 8 may be locked in place, andagainst adjacent walls of the annulus by an applied pressure createdthrough compression applied through the connecting member 6 and externalbarrier member 5″.

In practicing the present invention for the repair of a partial or fulldefect in the annular wall 3, an access sheath (e.g. a cannula, solidprobe, rod, needle, etc.) 13 or series of sheaths, optionally housing anobturator 14, as depicted in FIG. 12 may be inserted through apercutaneous incision in the external skin and extended throughunderlying tissue to the AF using techniques known in the art. It isrecognized that in some circumstances, a series of sheaths may be usedto gradually dilate an access tract to, and in some instances, throughthe defect. If desired, a final sheath 13 can be left in place, throughwhich the delivery instruments of this invention can be positioned.Guide wires or other similar elements can be used to guide the deliveryinstrument to the defect site, through techniques common in the art.

In an embodiment, the access sheath 13 through which any subsequentinstruments or components may be inserted is preferably of a fixedlength. The subsequent instruments which may be directed through thesheath may incorporate that fixed length into their shafts, and extendout the distal end of the sheath by a precisely determinably amount, asthey may be calibrated or have markings, in order to allow the surgeonto determine the depth of penetration into the target tissue (e.g., intothe disc, thickness of the annulus, and zone of nucleus). As the sheathand obturator are directed to the target site, the obturator may beremoved and a trocar or tissue dilator (for example, tissue dilator 18of FIG. 21) is used to initially penetrate into the annulus fibrosis(AF) at the zone of the defect or tear. A sharp trocar or tissue dilator(which is preferably calibrated along at least a portion of its length)may be inserted through the access sheath 13 to the surface of the AF atthe location of the tear and confirmed in some manner (e.g., viaradiography). It is envisioned that multiple increasing diameters and/orlengths of trocars or tissue dilators may be used to gradually open alumen within the AF. The instruments inserted into the living being,(e.g. the sheath, trocar, and obturator, etc.) may feature monitoringelements (e.g., radiopaque markers, bands, penetration markers,orientation markers, calibration, etc.) to allow accurate tracking,placement and implementation of the devices using techniques known inthe art (fluoroscopy, x-ray visualization, etc.). The trocar may then beadvanced into the disc, for example through the AF to the level of theNP. The trocar may then be removed, thereby creating an accessible openlumen within the cannula or access sheath 13, such that the elongatedelivery device 15 of FIG. 13, shown here in cross-section containing anembodiment of the treatment device, may be inserted into and extendthrough the access sheath 13 as depicted in FIG. 14.

As illustrated in FIG. 13, one embodiment of the treatment device orclosure device includes a distal barrier 5 attached to at least oneconnecting elements 6 and 6′. The barrier element 5 depicted here is inthe form of a flexible mesh-like material capable of being collapsed andstored within the distal portion of the delivery instrument 15 for laterejection into the wound area for placement adjacent the opening ordefect upon deployment. In another embodiment, a sealing element may beincluded as an intermediary component that is located contiguous withthe connecting members 6′ and/or 6, and adjacent the barrier element tofacilitate the filling of the defect upon delivery. Also shown in FIG.13 are passage means 60 and 60′, which are stored while recessed, inchannels 62 and 62′, respectively, in the body of the deliveryinstrument 15. As will be described later, the passage means 60 and 60′in this embodiment can be extended out of the distal portion of thechannels to pierce the tissue surrounding the defect. As will also bedescribed later, the passage means are used to pass the connectingelement(s) through the tissue adjacent to the defect. The device mayhave one or more passage means, optimally the device would have at leasttwo. Also shown in FIG. 13 are positioning elements 70 and 70′. Thepositioning elements are deployed to position a portion of theconnecting element 6 and/or 6′ to a location where the passage means 60and 60′ can cause the connecting elements 6 and 6′ to pass through thetissue adjacent the defect. As will be described, the positioning meanscan expand laterally, and preferably radially from the elongate deliveryinstrument 15 such that when passage elements 60 and 60′ are no longerrecessed in channels 62 and 62′, but instead extend distally from thebody of the elongate delivery instrument 15, the passage elements willintersect with the desired portion of the connecting element 6 and 6′.Preferably, the passage elements 60 and 60′, will interlock or becomeattached to the connecting elements 6 and 6′ upon intersecting, and asthe passage elements are retracted, they will draw a portion of theconnecting elements with the passage elements, thereby directing atleast a portion of the connecting elements through the tissue adjacentthe defect.

FIG. 14 depicts an alternative embodiment of the delivery device 15within the access sheath 13, and is prepared for being introduced intothe disc through percutaneous puncture, and extended into an aperturecreated in the AF to the level of the NP for delivery and implementationof the remaining components of the device (e.g. the closure deviceelements). FIG. 14 depicts an alternative form of a barrier element 5″,wherein the barrier element 5″ is fabricated from a more rigid materialsuch as nylon, PLGA, etc. In this embodiment, the delivery device 15 maybe calibrated along its proximal end relative to the proximal edge ofthe access sheath 13 to allow the surgeon to determine when the barrierelement 5′ has traversed a distance approximately equal to the thicknessof the AF. Alternatively, other location detection mechanisms may beutilized in ensuring accurate placement of the delivery device forplacement of a fastener or closure device.

With reference to FIGS. 13 and 14, the delivery device 15 may be shapedor incorporate elements that deploy the device components (e.g. barrierelement 5, sealing element, etc.), such as a tamping or ejectingmechanisms, or a rod that can be extended down through the elongatedelivery device 15 to eject the closure device elements, such as thebarrier, as may be necessary.

In this or other embodiments, the use of a means for location detectionmay be beneficial. In FIG. 15 there is shown embodiment of a locatingdevice for effecting the proper positioning of the access sheath 13 orother deliver device within the annulus or nucleus. As can be seen inFIG. 15, the depicted embodiment of a locating device basicallycomprises a conventional obturator 14 providing a passageway 402extending longitudinally down substantially the length of the device,preferably internal to the obturator, although external may be capableof functioning similarly. In the embodiment having an internalpassageway lumen 402, a detection port 404 extends radially inward intothe device communicating with the distal end of the passageway 402,while a proximal port 406 extends radially inward into the devicecommunicating with the proximal end of the passageway 402. The locatingdevice is arranged such that it may be fully inserted within the accesssheath 13 and extend a precise amount beyond the end of the accesssheath, as shown in FIG. 15, and further the proximal port does notenter the proximal end of access sheath 13, thereby ensuring thatproximal port 406 remains accessible or visible to the operator.

The length of the annular passageway 402 is selected so that when theobturator 14 of the locating device shown in FIG. 15 is fully extendedwithin the access sheath 13 and the distal end of the sheath is locatedwithin the interior of the annulus or lumen, the detection port 404 ofthe passageway 402 extends just beyond the free end of the sheath, whilethe entrance port 406 is accessible to the operator. The detection port404 forms a window, which is exposed to the material in the annulus.

In another embodiment of the location detector of FIG. 15, a flexible orreconfigurable member (e.g. a probe) (not shown), may be inserted intoproximal port 406 and extended through the passageway 402, exiting atdetection port 404, such that the flexible probe or member may be usedto probe the tissue, thereby using, for example, tactile feel to locatethe sheath or other insertion member, such that a device maysubsequently be accurately placed.

In another embodiment of a location detector, sensors (not shown) may beplaced at or near the distal end, such as within detection port 404 toconfirm accurate placement. Such sensors may be in the form of, forexample, optical sensors or pressure sensors that may be exposed to thetissue or fluid during placement of the device, and generate anindicator signal or other feedback for the operator and enableconfirmation of accurate placement of the device.

Description of an Exemplary Procedure for Repair of a Defect in the AFUsing the Device of the Present Invention

With reference to FIG. 3, there is depicted a typical defect 9 in avertebral disc 16, here shown as a full tear in the annulus 3. In thepractice of the present invention, various techniques known in the artmay be utilized for the introduction of the closure device through adelivery device in order to repair such a tear in the annulus. Thefollowing description of one delivery technique is for example only, andis not intended to limit the inventor to only this practice, as othersimilar or equivalent delivery techniques are available and known in theart, and the practice of the present invention through these equivalentprocedures is inherent within the description.

As depicted in FIG. 16, an access cannula 13 (e.g. a needle) may bepositioned through a defect 9 in the annulus 3, and the needle extendedinto the interior of the annulus (i.e. the nucleus pulposus 4) usingstandard techniques known in the art, preferably radiographic techniques(e.g. x-ray). As shown in the exploded view of FIG. 17, the cannula 13may initially have an obturator 14 as shown, which may serve to preventtissue from entering into the central lumen of the cannula while it isbeing directed through tissue. Upon insertion of the cannula 13 into theinterior of the disc 16, the obturator 14 may be removed, leaving anempty lumen in the cannula 13 for the introduction of the deliverydevice, as will be discussed. Alternatively a guidewire 12 or otherwire-like element may be introduced into the cannula (as can be seen inexploded form in FIG. 18, and in place in FIG. 19). The use of aguidewire 12 will allow the replacement of the first inserted cannula oraccess sheath 13, to be replaced with another access sheath suitable forpassing the elongate delivery device therethrough (to be discussed) thatmay be advanced along the placed guidewire 12.

With reference to FIG. 20, after removal of either or both of theobturator 14 (from FIG. 17) or the cannula 13 (from FIG. 19), theguidewire 12 or wire-like element can be left in the puncture or defect9 and may serve to guide access sheath 13 suitable for use with thedelivery system of the present invention (e.g., delivery system 15 ofFIG. 13 or 14) to the appropriate position at the target site. Asdepicted in FIG. 21, the access sheath 13 may optionally utilize atleast one tissue dilator 18 (e.g. trocar, obturator, etc.) that isarranged to expand the initial opening or defect 9 in the annulus 3 to asize capable of allowing the penetration of the access sheath 13, andassociated elongate delivery device 15 housing a closure device into theopening created. It is recognized that a series of tissue dilators 18and or access sheaths 13, increasing in size may be utilized to achievean aperture of greater size in the tough annulus layer 3 than theoriginal opening or defect 9 created in FIG. 16. In use, the tissuedilator 18 is inserted through the access sheath 13, and extendsdistally therefrom, forming a tapered snout that serves to expand thetissue, such as in annulus 3, to the point where the access sheath 13suitable for use with the delivery device 15 may be inserted.

As the access sheath 13 is positioned over the guidewire 12 and advancedinto the aperture, as seen in FIG. 21, various techniques for ensuringthe positioning of the device are available. For example, radiopaquemarkers (not shown) can be used to properly locate the sheath at theideal position. Alternatively, other location detector mechanisms, asdescribed previously or known in the art, may be utilized.

In the embodiment where an access sheath 13 incorporates an expandableor reconfigurable locking member 22, as can be seen with reference toFIGS. 22-26, located at or near the distal end of the access sheath 13,the locking member 22 may also function as a location detector. In thismanner, the actuation of the expandable or reconfigurable locking membermay provide feedback or tactile sensations to the operator as to thetype of tissue is being encountered, thereby allowing the operator todistinguish placement within the annulus 3 from placement within thenucleus 4. For the practice of this embodiment, it is preferred that thetissue dilator 18 and wire 12 be removed, as depicted in FIG. 22,leaving the access sheath 13 penetrating into the disc 16.

As shown in FIG. 23, actuation mechanism 23 is used to deploy orreconfigure the locking mechanism 22 to provide location detection. Theactuation of the expandable or reconfigurable locking member 22 may beaccomplished by various means (e.g. inflation, or mechanical actuation).As shown in FIG. 23, with this particular embodiment, actuationmechanism 23 is preferably located at the proximal end of the accesssheath 13, and may be rotatable, and upon rotation, or in the case of aninflation port, upon delivery of an inflation charge, serves to actuatethe locking member 22 at the distal tip of the sheath 13, causing thelocking member 22 to expand via one of several mechanisms (e.g. balloonexpansion, nitinol wings, etc.). In the instance where the actuation ofthe locking member 22 were to cause the locking member to encountertough annulus tissue, this would serve as an indicator to the operatorthat the sheath must be advanced into the nucleus, until softer nucleusmaterial is encountered, allowing easier expansion of the locking member22. The mechanisms (e.g. balloon, nitinol wings, etc.) may also be usedto prepare a physical space for the delivery of the device. For example,the balloon can be inflated to a large initial diameter to stretch orotherwise move tissue. Then the balloon can later be reduced in size toprovide a deployment space for a component of the device (such as abarrier or sealing member). In the case of an embodiment having anotherexpandable mechanism, such as nitinol wings, the expandable mechanismmay be expanded and optionally through the rotation or translation ofthe access sheath, or other instrument upon which the mechanisms aremounted, a physical space can be created to allow for proper deploymentof the remaining components of the device.

With reference to FIG. 24, the operator or surgeon may retract theaccess sheath 13 until the desired location is achieved using a locationdetection means as described preciously. Resistance may be felt as thelocking member 22 first traverses relatively freely through a portion ofthe nucleus 4 and subsequently encounters the tougher annulus 3 tissue,thereby providing the resistance to further refraction. Optionally, andas shown in FIG. 25, a locking mechanism (e.g. a locking ring) 24 may beadvanced down the access sheath 13 in a proximal to distal fashiontoward the puncture (i.e., against the skin or tissue of the patient) tostabilize the access sheath 13.

As shown in FIG. 26, the elongate delivery device 15 containing theclosure device of the present invention may now be inserted into theaccess sheath 13. In a preferred embodiment, the anchoring or barrierelement 5 is contained within and in place at or near the distal end ofthe delivery device 15 (as described previously with reference to FIGS.13 and 14), and is temporarily maintained in alignment with the axis ofthe access sheath 13 to allow passage into the sheath 13. It is alsocontemplated that the delivery device 15 could be introduced into thedefect without the use of an access sheath. The delivery device 15 couldbe modified to include a passageway that would permit it to be guidedinto the defect site over a guide element 12 (e.g. guidewire, k-wire,etc.). The delivery device 15 could also include a rounded or moreatraumatic tip to assist with passage through the tissue.

As shown by FIG. 27, upon full insertion of the delivery device 15 intothe access sheath 13, the distal portion of the device 15 extends beyondthe access sheath 13. Also with reference to FIG. 27, a locking tab 26may be incorporated onto the proximal end of the delivery device 15. Asthe delivery device 15 is fully inserted, the locking tab encounters theaccess sheath 13. The locking tab 26 is capable of one-way movement overthe access sheath's 13 proximal end, and will then become engaged withthe access sheath such that the access sheath 13 and the delivery device15 are now interlocked as one unit.

As shown in FIG. 28, the expandable or reconfigurable locking member 22,located at or near the distal end of access sheath 13, may de-actuated,such as through the action of actuation mechanism 23, such that itreverts back to its original, non-expanded state.

Also as shown in FIG. 28, activation of a secondary actuation mechanism(e.g., lever) 80 causes the deployment of positioning elements 70 at thedistal portion of delivery instrument 15. As described previously, thedelivery device may have any number of positioning elements 70 as isnecessary for the application. The positioning elements may extend inone axis, presenting a pair of positioning elements upon actuation.Alternatively, several positioning elements (e.g. 3 or more) may besimultaneously deployed to form a flange or series of protrudingelements extending laterally from the body of the delivery device 15 inmany axis or orientations.

If desired, the access sheath 13 and delivery device 15 can be withdrawnas one unit to a desirable location as is necessary. For example, asshown in FIG. 28, delivery device 15 and access sheath 13 are withdrawnas one unit from the defect until the laterally deployed positioningelements 70 contact the interface between the annulus 3 and the nucleus4. In this embodiment, positioning elements 70 may also be capable offunctioning as a location detector in a manner similar to thatpreviously described with reference to the expandable locking member. Inthis manner, the actuation of the expandable or reconfigurablepositioning elements may provide feedback or tactile sensations to theoperator as to the type of tissue is being encountered, thereby allowingthe operator to distinguish placement within the annulus 3 fromplacement within the nucleus 4.

As shown in FIG. 29, activation of plunger 90 causes the deployment ofpassage elements 92 from the distal portion of delivery instrument 15.As described previously, the device 15 may have any number of passageelements as is necessary for the application. The passage elements canbe constructed and configured to readily pierce through the tissue thatis adjacent the delivery instrument (e.g., a needle). Each passageelement 92, upon deployment in response to activation of plunger 90, isarranged to intersect a respective positioning means 70 and therebyengage the connecting members 6 associated with each positioning means.The engagement of the passage means and the connecting member may beaccomplished in a manner that ensures the secure, one-way, connectionbetween connecting member 6 and the respective passage element 92.

As shown in FIG. 30, plunger 90 may then be refracted, therebywithdrawing the passage means 92 back through the tissue, and into therecessed channels of the delivery instrument 15. The retraction of thepassage elements 92 causes the securely attached connecting elements 6to pass along the same passage, through the tissue adjacent to thedelivery instrument and enter into the recessed channels of the deliveryinstrument. After complete refraction of the passage elements, a portionof the connecting elements remain within the internal lumen of thedelivery device, attached to the remaining components of the fastener,and another portion of the connecting element (e.g., a filament) isextended along the passage created by the deployment of the passagemeans, and attached to the passage means contained within the recessedchannels of the delivery device. Secondary actuation mechanism 80 maythen be deactivated, thereby collapsing the positioning elements 70 backto their original, more compact state.

As shown in FIG. 31, the delivery instrument 15 and access sheath 13 canbe withdrawn form the defect site as one unit. Upon withdrawal of thedelivery instrument 15, the components of the fastener may now bedeployed; barrier member 5 is deployed from the distal portion ofdelivery instrument 15 and the continued withdrawal of delivery devicedraws the connecting elements through the tissue that is adjacent to thedefect 9. Tension upon the fastener components (e.g., barrier member,sealing member and connector elements, etc.) may be maintained throughthe at least one connector element 6 by the retraction of the deliverydevice 15, and the resistance of the barrier member 5 as it encountersthicker nucleus tissue or tough annulus tissue, as depicted in FIG. 32.

As further depicted in FIG. 32, connecting elements 6 can be placed intension, such as being pulled taught, by continued withdrawal of thedelivery instrument, and securement member 17 can be advanced along theconnecting elements 6 to a desired position to secure the barrier member5 and the connecting members 6 at the desired location to helpapproximate and or treat the tissue contiguous to the defect site 9.Subsequently, excess connector element may be removed, or trimmed tominimize the opportunity for complications as healing occurs (e.g.,infection, irritation, scarring, etc.).

The securement element 17 may be positioned, in one embodiment, againstthe outside of the puncture in the annulus 3, and internal to thepatient. Alternatively, the fastening element 17 may be placed outsideof the patient and against the skin where the connector element entersthe tissue. The securement element 17 can be any of a variety of tensionmaintaining devices, for example, a locking washer, a knot, or a varietyof elements or combination of elements may be utilized. The securementelement 17 could be pre-stored within the delivery instrument 15 or itcould be added to the connecting members 6 by the physician during theprocedure. Further, a small-elongated tamper tube or other instrumentmay be utilized to push down or advance the securement element 17. Thetube is preferably removed after securing the securement element 17.Alternatively, a pulley configuration could be used with a securementelement 17 in the form of a sliding locking knot, and would not requirethe use of an elongated tube to apply tension, as the operator appliestension simply by pulling on the connector element 6, whereby the pulleyarrangement and sliding locking knot are arranged to maintain thattension. Glue or some other sealant or adhesive could also be used tosecure the device at the desired location.

Various embodiments of a closure device can be utilized in the practiceof this invention, as have already been described. As depicted earlierin FIG. 4, a sealing member 8 associated with a portion of the flexibleconnector element 6 may be deposited within the tissue as desired. Withthis embodiment, continued refraction of the access sheath 13 anddelivery device 15 results in the deployment of the sealing memberwithin the annulus tissue 3. Altering characteristics necessary for thevarious embodiments of the closure device, such as manipulating thelength of the connector element 6, and varying the placements of theaccess sheath 13 can achieve the deployment of the various describedembodiments of the closure device.

After the closure device is fully positioned at the tissue defect 9, anyextraneous connector element 6 or suture may be removed. As appropriateany of the embodiments of the device described in the specification maybe used to deliver various medications at the puncture site and to thesurrounding tissues. The delivery of such medications may beaccomplished as a coating of drug delivery material associated with oneor more of the fastener or device components, such as the barrier oranchor, sealing member, connector means, etc. It is also recognized thatthese or other components of the device may be manufactured from aresorbable material to deliver biologically active agents as thecomponents bioerode, thereby forming a depot. A non-exhaustive list ofexamples of drugs or biologically active agents is provided in Table 2.

Repair of Herniated or Bulging Annulus Fibrosis

An annular defect such as a bulge or herniation may be caused by or bethe result of weakening in the AF secondary to physiologic changes tothe AF or NP, and the AF may weaken and protrude from its normalanatomic space pushed by the internal NP as can be seen in FIG. 33. Inmore severe cases, the AF 3 may rupture and allow extravasation of theNP 4 contents to the surrounding anatomy (as depicted in FIG. 34).Symptoms may arise when the herniation (bulge) or leakage of the NPthrough the defect 9 in the AF 3 impinges on the nerve root 2 or spinalcord 1. There are many therapies currently utilized for treatment of theherniation (bulge) and resultant pain, starting with conservativetherapies such as bed rest and pain medicines, to epidural injections,to open or minimally invasive discectomies or to complete discectomy andfusion of the disc space and adjacent vertebrae. An object of thisinvention is to provide a minimally invasive means to contain leakage orto reduce the bulge or defect 9 created by one of the invasive treatmentmeans in an annulus to prevent impingement on the nerve roots or spinalcanal.

The previously described embodiments may also be useful for treatingherniated or bulging annulus defects. FIG. 35 illustrates an additionalembodiment of the device specifically envisioned for the treatment ofbulging or herniated discs. The treatment device consists of a distalbarrier 5′ which is arranged to rest against the external aspect of theAF 3 directly opposite the bulge 9 in disc 16 in the anterior-lateralportion of the AF 3. Connecting elements 6 traversing through the AF 3and NP 4, connects the distal barrier element 5′ to another barrier,proximal barrier 5″, which is arranged to rest against the bulge 9 inthe affected part of the AF 3 in the posterior part of the disc. Thebarriers 5′ & 5″, as previously described may be constructed of aresorbable polymer, resorbable collagen or other resorbable ornon-resorbable material. The barriers 5′ and 5″ may be somewhatflexible, but not so much as to pull through the delivery opening ordefect 9 upon the application of compression. In the preferredembodiment, barrier 5′ is comprised of a flexible membrane such as apolyethylene mesh and barrier 5″ is a more rigid material such as aninjection molded plastic. The barriers 5′ and 5″ may also contain smallbarbs or points 7 (as can be seen in FIG. 10A) to interface with theinternal or external surface of the AF 3 to prevent dislodging.Connecting members 6 may preferably be a suture, similar to thatdescribed above, and may be manufactured from polymers known in the art,including synthetic and natural polymers. In some embodiments of thedevice, the connecting member may also be associated with a sealingelement 8, as has been described above. The sealing or intermediatecomponent 8 may be arranged within the walls of the annulus 4, as shownin FIG. 11, and/or all or a portion of the NP 4, as shown in FIG. 36.The intermediate component or sealing member 8 may function to preventthe escape of NP through the defects 9 or openings created by theimplanting of the closure device. In an embodiment, the intermediatematerial or sealing member 8 may be treated with fibrin glue or othermeans by which it can stick to the opening or defect 9, or alternativelymay serve to deliver at least one therapy, drug or biologically activeagent, such as those listed in Table 2. It is recognized the suture orconnecting member 6 itself may feature a coating of a sealing materialor a therapy that may be delivered upon implantation in the livingbeing. All of the closure device components, including barriers 5,sealing member 8 and connecting members 6 may be non-resorbable forpermanent implantation, partially resorbable, or completely resorbable,such that a temporary implant may be achieved.

It is recognized that various other combinations of barrier placementare possible, varying in location and number. Barrier locations may varywithin a given embodiment, such as is depicted in FIG. 37, havingmultiple distal barriers 5′ against an interior aspect of the annulus 3and within the nucleus 4, and having a proximal barrier 5″ inside of thenucleus, inside the annulus, replacing a portion of the annulus, orexterior to the annulus. As shown here and in some other embodiments,the placement of multiple barriers may be necessary to provide thenecessary levels of support. Such multiple barriers placements may beseen in the exemplary embodiment of FIG. 37 where multiple distalbarriers 5′ are operating in parallel to maintain tension uponconnecting members 6 and upon proximal barrier 5″.

In an alternative embodiment of the device envisioned for the treatmentof bulging or herniated discs, as depicted in FIG. 38, the devicefeatures multiple barrier members 5′ which are arranged to rest againstthe exterior aspect of the AF 3 opposite the bulge 9 in disc 16 in theanterior-lateral portion of the AF. The placement of multiple barriermembers as shown herein serve to provide increased surface area overwhich to distribute a given load, which will necessarily be less thanthe load per unit area imposed by a single similarly sized barrierplaced against a bulge or defect 9, thereby overcoming the bulge andrestoring the normal appearance of the annulus 3.

With reference to FIGS. 35 and 36, depicting the process for repair of adefect 9 in the form of a hernia (bulge). In practicing this embodimentof the present invention for the repair of a herniated disc or bulge ordefect 9 in the annular wall 3, a cannula or access sheath 13 andobturator 14, as described above with reference to repairing a partialor full defect in the annular wall, may be inserted percutaneously anddirected towards the annular wall, preferably towards the defect 9 inthe annulus. As described previously, once the cannula 13 has passedthrough the soft tissue and is resting in the proper location againstthe annulus 3, ideally at the location of the herniation or bulge 9, theobturator 14 is removed and a trocar or tissue dilator 18 may beinserted and may be advanced into and/or through the annulus, therebycreating or expanding an aperture for the insertion of the deliverydevice. Furthermore, and in the case where the barrier 5′ is to berested against the outer aspect of the opposing portion of the AF 3, thetrocar or tissue dilator 18 may be advanced through the opposite AF aswell. The insertion of the trocar may be performed using standardtechniques known in the art. Upon verification of placement of thetrocar completely through the disc 16, such as is possible through theemployment of monitoring features such as detection location features(e.g., calibration of the trocar, radiographic visualization, or othermeans) the delivery device 15 housing the closure device may be insertedthrough the access sheath 13, and through the nucleus 4 space, exitingthe opposite side of the AF.

Once the delivery device has been passed through the AF, NP and oppositeAF the deployment of the fastener device is performed to arrive at theembodiment as depicted in FIGS. 35 and 36 having a distal barrier 5′external to the annulus 3. The steps for deployment and securement ofthe fastener components may be achieved in a manner similar to thatdescribed previously with reference to FIGS. 19-32, altering thecomponents and placements as needed to achieve the desired outcome.

Alternatively, the delivery device may remain within the NP and notextended out the opposite AF, and may deploy one or more distal barrier5′ against the internal aspect of the AF 3, with the result as depictedin FIG. 37. Deployment may occur by depositing the closure devicecomponents into place from the delivery sheath 15, for example, byutilizing a rod or other pushing device directed through the deliverysheath from a proximal location, which upon contacting one or morecomponents of the closure device causes each component to exit thedistal end of the delivery sheath. The location of each component of thedevice may be confirmed by various monitoring mechanisms as known in theart, e.g., radiopaque or other visible markers in combination with x-rayimaging or fluoroscopic imaging, positional markings or bands, etc.

Subsequently, and preferably as the delivery device 15 and/or accesssheath 13 is retracted, the connecting member 6, such as a suture may bedeployed, optionally in conjunction with a soft intermediate componentor sealing member 8 of the device, as can be seen in FIG. 36. Aspreviously described, the intermediate component 8 may be made of apolymer material, and may be resorbable (e.g., collagen). Furthermore,the intermediate component may contain some bioactive substance,therapy, or drug, such as those listed in Table 2. It is recognized thatany of the resorbable or non-resorbable components utilized in thepractice of the invention may also beneficially delivery a biologicallyactive agent as well, such as pain reducing or inflammatory reducingagents, or other drugs. The intermediate component 8 including anybioactive substance, either together, or alone, may act to improve thehealing of the defect. It is recognized the intermediate component 8 maybe made of a rigid polymer similar to the barrier 5. Compression may beapplied to the AF 3 and the bulge defect 9 upon removal of the deliverydevice 15 and/or annular sheath 13 from the disc 16, and deployment ofholding mechanism or fastening element 17 (e.g., an automatic slip knot)which when pushed against the proximal barrier 5″, or in the case of arigid intermediary component, the holding element may be pushed againstthe intermediary component 8, and maintains tension upon the connectingmember 6. This tension results in compression created between barriers5′ and 5″, such that the act of compression alone may act to reduce thebulge defect 9 in the AF 3, thereby relieving or preventing impingementon the nerve root 2 or spinal cord 1, and resulting pain or harm.Additionally, the implanted fastener or closure device may act toprevent subsequent extravasation of the contents of the NP 4 through thebulge or defect 9, and may provide a scaffold, such as may occur if madeof a collagen or other porous material, to support the regeneration ofthe AF. The internal connector or coupling mechanism 6, extending outfrom the disk proximally may then be removed at a convenient location toencourage healing, e.g., such as being severed at the surface of theskin, in order minimizing irritation, inflammatory response andopportunity for infection.

Repair of the Annulus Fibrosis Secondary to Placement of a NucleusPulposus Implant Material

Newer approaches to the repair of the degenerated intervertebral discand specifically the degenerated NP have envisioned the removal,replacement, and/or augmentation of the natural NP material with anartificial nucleus replacement material designed to mimic the naturalmechanical properties of the NP. In this manner, normal disc functionmay be restored by the insertion of a synthetic or natural materialthrough the annulus and into the nucleus.

As can be seen in FIG. 39, the nucleus replacement implant material 25may be a material capable of being delivered by a delivery apparatus 27(for example, being injected via a needle, cannula or other suitableinstrument, or being placed through a cannula, sheath or other suitableinstrument), into the region of the nucleus 4, either with, or withoutremoving the existing NP. The material 25 may then remain entrapped,either permanently or temporarily, within the annulus 4, and restore thenatural mechanical function of the nucleus pulposus 4. Examples ofmaterials suitable for injecting and serving as a nucleus replacementinclude synthetic or natural hydrogels (e.g., collagen gels, PEC gel,etc.) Alternatively, an injectable implant material 25 may be injectedas a liquid, hydrogel, or paste, and harden or cure in-situ to become aself-supporting implant material 25. This material may serve tosupplement the mechanical properties of the degenerated NP, or in thecase of complete nucleus removal, the implant material would replace theNP and mimic the natural biomechanical and viscoelastic properties ofthe disc.

Alternatively, the nucleus implant material 25 may be a self-supportingmaterial, resilient or otherwise (e.g. solids, porous foam, collapsibleresilient cage, disc or stent structure, etc.), at the time of beingimplanted. There are currently several developmental attempts to addressthis approach, most notably in the form of a device utilizing apartially hydrolyzed polyacrylonitrile housed within a polyethylenejacket (manufactured by Raymedica), and an implant utilizing Aquacryl 90which is a modified poly-acrylonitrile (PAN) that can take up to 90% ofits weight in water (manufactured by Replication Medical). This materialis bonded to internal Dacron meshes and is partially hydrated and uponinsertion provides anisotropic axial expansion

The self-supporting implant material 25 utilized in this embodiment ofthe present invention may be provided in various shapes or conformations(e.g., collapsed, preshaped to a particular portion of the disc or theentire disc, etc.). The implant material 25 may be implanted in a firstconformation, and following implantation take on a second conformation,for example, a collapsible implant may expand after being placed withinthe nucleus due to physical means or rehydration, and arrive at a secondconformation due to the anisotropic properties of the material.

In the practice of the technique of NP replacement or augmentation, theintegrity of the natural AF 3 would necessarily be compromised to allowthe insertion of the implant material. For example, in order tofacilitate delivery of the NP filling implant material 25, and in thecase of an injectable implant material 25, a delivery apparatus 27 inthe form of a needle may be directed through the soft tissue to theouter level of the AF 3, then through the AF and into the nucleus 4 inorder to deliver the implant material 25. The delivery apparatus 27 uponpenetrating through the AF, may be directed through an existing defect,or alternatively may create a defect 9, which may or may not requirerepair through the techniques described herein. It is also a techniquethat a cannula/obturator may be a suitable delivery apparatus 27 for anucleus replacement implant material 25, and may be inserted to thelevel of the AF 3, an opening created either through the placement ofmultiple trocars through the AF or alternatively through the use of acoring/cutting tool to create a lumen in the AF for the removal of theNP and subsequently for the injection of the material. Alternatively,for a solid implant material 25, an opening in the AF must be created toallow the removal of the degenerated NP and insertion of the implantmaterial. In order to implant solid or self-supporting devices whosesize is at or near that required to fill the nuclear space 4, arelatively large opening or defect 9 must be utilized or created in theAF 3 to allow removal of the NP material and insertion of theself-supporting implant material 25. If left un-repaired, there havebeen reports in the literature of expulsion of such devices. It isrecognized that a collapsible or deformable self-supporting implant mayserve to minimize the opening required to implant the device. In anyevent, it is desirable to contemplate the filling and repair of thedefect 9 in the AF 3 to reduce the risk of expulsion of the implantmaterial 25 and to support the repair and regeneration of the AF.Furthermore, in order to prevent potential extravasation of the fillingmaterial 25 after implantation, and to reinforce the mechanicalintegrity of the AF 3 or to potentially regenerate the AF, a fastener orclosure device of the present invention may be utilized to ensure thatthe opening created in the AF to deliver the NP filling material isclosed, as can be seen with reference to FIG. 11, where the nucleus 4would be replaced with an implant material (not shown). The implantmaterials 25 contemplated may utilize natural matrices, which canfacilitate or enhance the in-growth of cells and tissue and ultimatelyfacilitate the regeneration of the AF, providing a more naturalconstruct.

Following the implantation of the artificial NP implant material 25(whether injectable or self-supporting), the fastener or closure deviceof the present invention may be directed through the same access openingin the annulus through which the injection or insertion occurred, toseal the opening or defect 9. This repair may occur in a substantiallysimilar manner as has been described with reference to any of thetechniques described above for repairing a defect in the annulus,particularly the techniques described to treat the defect remaining in adiscectomy procedure. These techniques are particularly well suited forrepairing defects that are created through the use of injectable nucleusreplacement materials. Especially in the case of NP repair orreplacement with a solid implant, there may be a need to repair a muchlarger breach in the AF.

Any or all of the embodiments of the present invention may beneficiallyincorporate a location detection means that is capable of providing foraccurate positioning and placement of the device by sensing or otherwiseallowing the detection of the location of the device within the anatomy.More specifically, the location detection means may allow the detectionof the location of the device in order to ensure the proper placement ofthe components of the device within the annulus, nucleus, and/or theinterface between the annulus and nucleus. Additionally, the locationdetection means may also serve as a locking member to maintain aposition of at least a portion of the device with respect to the body.

Various methods disclosed herein could be used for such purposes. Oneembodiment would include the use of an expanding balloon or anarticulating wing or finger to locate the interface between the nucleusand annulus, and assure proper placement of the closure or treatmentdevice. By way of example, the delivery instrument could have anexpandable or reconfigurable member (e.g. flange, balloon, anchor,finger, foot plate, etc.) that can be used to help locate the transitionbetween the annulus and nucleus or other adjacent tissues. Suchexpandable or reconfigurable members could help provide an indication ofproper location for device placement as well as help to create aphysical space into which a device can be implanted. The system could beadvanced into the appropriate tissue and then the expandable orreconfigurable element could be activated, the device could bewithdrawn, advanced, or otherwise manipulated until an indicatorprovides a signal that the device is at the desirable location. Conceptsof this approach could employ “tactile feel” as one indicator, to sensewhen a delivery system is at the appropriate location. Similarly,sensors may be utilized at or near the distal end of the device toconfirm placement, such as an optical sensor or pressure sensor that maybe exposed to tissue during placement of the device, and enableconfirmation of accurate placement of the device.

It is recognized that such an expandable or reconfigurable member mayalso beneficially serve to stabilize the disc, and or the components ofthe invention during and after placement of the device. Additionally,other stabilizing components may be utilized to achieve proper placementof the device, such as a sliding ring, flange, or other component thatmay be delivered following the insertion of a delivery tube or sheath,and placed against the target site, or the surrounding tissues to lendstability to the device. As can be seen with reference to FIGS. 36-46,and to be discussed in further detail below, the expandable member maybe expanded against the annulus interior wall, thereby preventing theretraction of the positioning device from the nucleus, and stabilizingthe positioning member. Optionally, a slidable flange may be advancedalong the body of the positioning device in order to apply securingpressure against the exterior of the annulus, or other tissue, therebymaintaining the accurate placement of the positioning device. The flangemay be advanced by external application of force, or alternatively, maybe advanced by operation of an advancing mechanism, such that theslidable flange is directed towards the distal end of the positioningdevice.

In another embodiment of a location detection means, a cannula or accesssheath may be provided having a separate pathway (e.g. a lumen) forproviding a location probe. The separate pathway may have an exit portlocated at or near the distal end of the delivery system. A flexible orreconfigurable member may be extended, either through the device, orfrom the device, and allow the surgeon to gauge the nature of thetissue, such as through tactile feel. A member being inserted intonucleus pulposus material would relay tactile information that thetissue is soft, as it would easily yield to advancement of the probe. Incontrast, the tough fibrous annulus material would provide greaterresistance to the advancement of the probe, affording similarconfirmation of placement of the device.

In another embodiment, the location detection means may rely oncalibrated insertable components, such as needles, delivery sheaths, orcannulas, which may be provided having graduated markings to indicatedepth of penetration, and allow proper placement of the repairingcomponents of the device.

It is also recognized that the use of markers or bands (e.g.radiographic markers, visual markers, etc.) may provide locationinformation for any of the described embodiments, such as through theuse of radiographic techniques (e.g. MRI, X-ray, etc.), and further aidin ensuring the proper placement of the device of the present invention.

Thus since the invention disclosed herein may be embodied in otherspecific forms without departing from the spirit or generalcharacteristics thereof, some of which forms have been indicated, theembodiments described herein are to be considered in all respectsillustrative and not restrictive, by applying current or futureknowledge. The scope of the invention is to be indicated by the appendedclaims, rather than by the foregoing description, and all changes whichcome within the meaning and range of equivalency of the claims areintended to be embraced therein.

TABLE 1 Examples Of Suitable Materials Aliphatic polyesters BioglassCellulose Chitin Collagen Types 1 to 20 Native fibrous SolubleReconstituted fibrous Recombinant derived Copolymers of glycolideCopolymers of lactide Elastin Fibrin Glycolide/l-lactide copolymers(PGA/PLLA) Glycolide/trimethylene carbonate copolymers (PGA/TMC)Hydrogel Lactide/tetramethylglycolide copolymers Lactide/trimethylenecarbonate copolymers Lactide/ε-caprolactone copolymersLactide/σ-valerolactone copolymers L-lactide/dl-lactide copolymersMethyl methacrylate-N-vinyl pyrrolidone copolymers Modified proteinsNylon-2 PHBA/γ-hydroxyvalerate copolymers (PHBA/HVA) PLA/polyethyleneoxide copolymers PLA-polyethylene oxide (PELA) Poly (amino acids) Poly(trimethylene carbonates) Poly hydroxyalkanoate polymers (PHA)Poly(alklyene oxalates) Poly(butylene diglycolate) Poly(hydroxybutyrate) (PHB) Poly(n-vinyl pyrrolidone) Poly(ortho esters)Polyalkyl-2-cyanoacrylates Polyanhydrides PolycyanoacrylatesPolydepsipeptides Polydihydropyrans Poly-dl-lactide (PDLLA)Polyesteramides Polyesters of oxalic acid Polyethylene GlycolPolyethylene Oxide Polyglycan Esters Poly(Glycerol Sebacate)Polyglycolide (PGA) Polyiminocarbonates Polylactides (PLA)Poly-l-lactide (PLLA) Polyorthoesters Poly-p-dioxanone (PDO)Polypeptides Polyphosphazenes Polysaccharides Polyurethanes (PU)Polyvinyl alcohol (PVA) Poly-β-hydroxypropionate (PHPA)Poly-β-hydroxybutyrate (PBA) Poly-σ-valerolactone Poly-β-alkanoic acidsPoly-β-malic acid (PMLA) Poly-ε-caprolactone (PCL) Pseudo-Poly(AminoAcids) Starch Trimethylene carbonate (TMC) Tyrosine based polymersAlginate Bone allograft or autograft Bone Chips Calcium CalciumPhosphate Calcium Sulfate Ceramics Chitosan Cyanoacrylate CollagenDacron Demineralized bone Elastin Fibrin Gelatin Glass GoldGlycosaminoglycans Hydrogels Hydroxy apatite Hydroxyethyl methacrylateHyaluronic Acid Liposomes Mesenchymal cells Nitinol Osteoblasts Oxidizedregenerated cellulose Phosphate glasses Polyethylene glycol PolyesterPolysaccharides Polyvinyl alcohol Platelets, blood cells RadiopacifiersSalts Silicone Silk Steel (e.g. Stainless Steel) Synthetic polymersThrombin Titanium Tricalcium phosphate

TABLE 2 Examples of Biologically Active Agents Adenovirus with orwithout genetic material Alcohol Amino Acids L-Arginine Angiogenicagents Angiotensin Converting Enzyme Inhibitors (ACE inhibitors)Angiotensin II antagonists Anti-angiogenic agents AntiarrhythmicsAmiodarone Lidocaine Sotalol Procainamide Diltiazem Anti-bacterialagents Antibiotics Erythromycin Penicillin Imipenem Zosyn Cipro FlagylVancomycin Anti-coagulants Heparin Lovenox Anti-Fungals Anti-growthfactors Anti-inflammatory agents Dexamethasone Prednisone AspirinHydrocortisone Antioxidants Anti-platelet agents Forskolin GP IIb-IIIainhibitors eptifibatide Anti-proliferation agents Rho Kinase Inhibitors(+)-trans-4-(1-aminoethyl)-1-(4-pyridylcarbamoyl) cyclohexaneAnti-rejection agents Anti-restenosis agents Adenosine A_(2A) receptoragonists Rapamycin Antisense Anti-thrombogenic agents ArgatrobanFondaparinux Hirudin GP IIb/IIIa inhibitors Anti-TNF Anti-viral drugsArteriogenesis agents acidic fibroblast growth factor (aFGF) angiogeninangiotropin basic fibroblast growth factor (bFGF) Bone morphogenicproteins (BMP) epidermal growth factor (EGF) fibringranulocyte-macrophage colony stimulating factor (GM-CSF) hepatocytegrowth factor (HGF) HIF-1 Indian hedgehog (Inh) insulin growth factor-1(IGF-1) interleukin-8 (IL-8) MAC-1 nicotinamide platelet-derivedendothelial cell growth factor (PD-ECGF) platelet-derived growth factor(PDGF) transforming growth factors alpha & beta (TGF-.alpha., TGF-beta.)tumor necrosis factor alpha (TNF-.alpha.) vascular endothelial growthfactor (VEGF) vascular permeability factor (VPF) Bacteria Beta blockerBlood clotting factor Bone morphogenic proteins (BMP) Calcium channelblockers Carcinogens Cells Stem cells Bone Marrow Blood cells Fat CellsMuscle Cells Umbilical cord cells Chemotherapeutic agents 5-FU CeramideCisplatin Cyclophosphamide Doxorubicin Flutamide Imatinib LevamisoleMethotrexate Mitomycin Oxaliplatin Paclitaxel Tamoxifen Taxol TopotecanVinblastine Cholesterol reducers Chondroitin Clopidegrel (e.g., plavix)Collagen Inhibitors Colony stimulating factors Coumadin Cytokinesprostaglandins Dentin Etretinate Genetic material GlucosamineGlycosaminoglycans GP IIb/IIIa inhibitors L-703,081Granulocyte-macrophage colony stimulating factor (GM-CSF) Growth factorantagonists or inhibitors Growth factors Autologous Growth FactorsBovine derived cytokines Cartilage Derived Growth Factor (CDGF)Endothelial Cell Growth Factor (ECGF) Epidermal growth factor (EGF)Fibroblast Growth Factors (FGF) Hepatocyte growth factor (HGF)Insulin-like Growth Factors (e.g. IGF-I) Nerve growth factor (NGF)Platelet Derived Growth Factor (PDGF) Recombinant NGF (rhNGF) Tissuenecrosis factor (TNF) Tissue derived cytokines Transforming growthfactors alpha (TGF-alpha) Transforming growth factors beta (TGF-beta)Vascular Endothelial Growth Factor (VEGF) Vascular permeability factor(VPF) Acidic fibroblast growth factor (aFGF) Basic fibroblast growthfactor (bFGF) Epidermal growth factor (EGF) Hepatocyte growth factor(HGF) Insulin growth factor-1 (IGF-1) Platelet-derived endothelial cellgrowth factor (PD-ECGF) Tumor necrosis factor alpha (TNF-.alpha.) Growthhormones Heparin sulfate proteoglycan HMC-CoA reductase inhibitors(statins) Hormones Erythropoietin Immoxidal Immunosuppressant agentsImmune modulator agents Inflammatory mediator Insulin InterleukinsInterlukins Interlukin-8 (IL-8) Lipid lowering agents Lipo-proteinsLow-molecular weight heparin Lymphocites Lysine MAC-1 Methylationinhibitors Morphogens Bone morphogenic proteins (BMPs) Nitric oxide (NO)Nucleotides Peptides Polyphenol PR39 Proteins ProstaglandinsProteoglycans Perlecan Radioactive materials Iodine - 125 Iodine - 131Iridium - 192 Palladium 103 Radio-pharmaceuticals Secondary MessengersCeramide Signal Transduction Factors Signaling Proteins SomatomedinsStatins Stem Cells Steroids Sulfonyl Thrombin Thrombin inhibitorThrombolytics Ticlid Tumor necrosis factor Tyrosine kinase InhibitorsST638 AG-17 Vasodilator Histamine Forskolin Nitroglycerin Vitamins E CYeast Ziyphi fructus

1. The method of supporting a defect in the tissue of a living beingcomprising the steps of: a) providing a delivery instrument comprisingan elongated instrument, at least one bridging member, and a pluralityof connector members; b) inserting said elongated instrument into saidtissue at or near the defect; c) deploying said connector members fromsaid delivery instrument into tissue at or near the defect; d)withdrawing said elongated instrument from said disc, thereby deployingand securing said bridging member to support said disc.
 2. The method ofclaim 1, wherein the method further comprises the additional step of: g)positioning at least one fastening element about said connector members,said fastening element being arranged to maintain tension upon saidconnector members.
 3. The method of claim 1, wherein said at least onebridging element is resorbable.
 4. The method of claim 3, wherein saidplurality of connector members are resorbable.
 5. The method of claim 1,wherein said connector members are three or more in number.